MAUDE Adverse Event Report: ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF; PASSER

Catalog Number 22-4038

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2018

Event Type  malfunction  

Event Description

It was reported that first pass needle would not target the teeth in the upper jaw.Back up was not available due to this a mayo needle was used to complete the case.No significant delay or patient injury reported.

Manufacturer Narrative

The reported disposable firstpass device, use in treatment, was not returned for evaluation.A relationship between the device and reported incident cannot be established as the product was not returned.From information provided, the first pass needle would not target the teeth in the upper jaw.A customer complaint cannot be verified due to the product was not returned for evaluation.Root cause is unable to determined; however the most possible cause may be due to incorrect suture or misuse of the device.The ifu was reviewed and was found to provide clear and thorough instructions for use.There are no indications to suggest the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

The reported disposable firstpass device was used for treatment and was returned for evaluation.Relationship between the returned devices and reported incident was not established as the device was able to function as intended.The returned disposable firstpass device was returned in good condition.No visual discrepancies were observed.Per information provided, the needle would not target the teeth in the upper jaw.Based on our visual evaluation of the returned device, no visual discrepancies were observed.The trigger, lever and upper jaw on the returned device were able to function as intended.During functional evaluation the two step trigger performed as intended.Suture were successfully loaded into the needle and passed through a piece of foam used to replicate tissue.The customer's complaint was not verified due to the device performed within expected parameters.Possible factors for the complaint could be if excessive force is be applied to the device when manipulating soft tissue, bone, or hard objects.Tissue thickness may affect suture placement including stitch depth and needle entry point.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7397930
• MDR Text Key: 104560627
• Report Number: 3006524618-2018-00166
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00817470012309
• UDI-Public: (01)00817470012309(17)201122(10)2008163
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2020
• Device Catalogue Number: 22-4038
• Device Lot Number: 2008163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Date Manufacturer Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1